MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP MED-DIST-TIBIAL PL 3.5 LOW BEND R 10; PLATE, FIXATION, BONE

Catalog Number 02.112.522

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Complainant device is not expected to be returned for manufacturer review/investigation.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during osteotomy procedure of a distal tibia, the surgeon cross inserted a 3.5 locking off axis and took noticed that he had potentially crossed threaded the screw.In the same surgery, the surgeon also bent a 3.5 cortex screw that he has used as a lag screw across.H left the screws in and completed the case successfully.No patient consequence.No surgical delay.This complaint involves 3 devices.This report is for one (1) lcp med-dist-tibial pl 3.5 low bend r 10.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a1: patient identifier: (b)(6).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCP MED-DIST-TIBIAL PL 3.5 LOW BEND R 10
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11966013
• MDR Text Key: 255195956
• Report Number: 2939274-2021-02847
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819374485
• UDI-Public: (01)07611819374485
• Combination Product (y/n): N
• PMA/PMN Number: K013248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.112.522
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 92